SFDA Medical Device Registration

CMC Medical Devices offers medical Device Registration in Saudi Arabia

We facilitate global registration in Saudi Arabia, ensuring regulatory compliance and efficient legal representation for your entry into the Saudi market.

Authorized Representative in KSA

You must also appoint an authorized representative in Saudi Arabia if you do not have an office or entity in Saudi Arabia.

Your Authorized Representative (AR) must obtain an Authorized Representative License, which is renewable annually, to legally represent you in KSA.

Your KSA authorized representative is also responsible for submitting all application documents to the SFDA to register your device. The SFDA assigns an official review period of 35 business days for applications; however, actual review times are often longer, especially if additional information is requested.

The recently established Saudi route by the SFDA requires a Technical File Assessment (TFA) for market authorization, and the SFDA has implemented its own classification system for medical devices.

Prior approval in the country of origin is not a prerequisite for registration in KSA, and reference country approval is not required for MDMA registration; however, any proof of existing approvals in other markets is requested as part of the registration documentation.

CMC can assist you in entering the Arab market by registering your products with the SFDA.

Select CMC as your GHAD SFDA

Complete the contact form and one of our consultants will get in touch as soon as possible.

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    Frequently asked questions about saudi arabia medical device regulations

    Yes, all medical devices, regardless of their risk classification, must be registered with the SFDA before they can be legally marketed or distributed in Saudi Arabia.

    Yes. The Free Sale Certificate is a key document for registration in Saudi Arabia.
    It must confirm that the device is legally marketed in the country of origin and must be issued by the relevant competent authority.
    Without this certificate, it is not possible to complete the registration process with the SFDA.

    Any Saudi-based entity or individual can act as your LAR, provided they are qualified and authorized to communicate with the SFDA on behalf of your company. The LAR handles submissions, communications, and ensures compliance with SFDA regulations.

    The Local Authorized Representative is responsible for submitting the application to the SFDA and handling all communications with the authority.
    Throughout the registration process, this local contact ensures that all administrative and technical requirements are properly managed.
    Having a representative established in Saudi Arabia is a mandatory requirement.

    The time frame can vary depending on the complexity of the device and the completeness of the submitted documentation. On average, the process can take several months, typically between 3 to 6 months, but it can be longer for high-risk devices.

    If you fail to register your device, you will not be able to market, distribute, or sell it in Saudi Arabia. Additionally, selling unregistered devices can result in legal penalties, product recalls, and fines.

    SFDA marketing authorization is valid for three years from the date of issuance.
    To maintain market access, the registration must be renewed before it expires.
    Planning ahead helps avoid delays or disruptions in commercialization.

    Yes, it is possible to change your representative after initial approval.
    This change must be formally notified to the SFDA in accordance with the authority’s established procedures.
    It is essential to manage the transition correctly to avoid any impact on the validity of the registration.

    Why appoint CMC Medical Devices as your GHAD SFDA?

    Fast response

    We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

    Efficient communication

    Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

    Immediate support

    We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

    Quick resolution

    Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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